Method and Apparatus for Securing a Patient&#39;s Limb

ABSTRACT

A limb support apparatus and corresponding methods for making same are disclosed. The limb support can comprise a shell for supporting a patient&#39;s limb during treatment, examination, and/or recovery. The shell can comprise at least one padding configured to protect the patient&#39;s limb. The padding can be secured to the shell using one or more mounting structures included in the padding. The mounting structures are configured such that they are received by corresponding mounting openings and/or features in the shell. An interference fit between the mounting structures and mounting openings/features secures the padding against the shell, thereby preventing the padding from inadvertently moving or sliding on the shell. Embodiments disclosed herein eliminate the need for traditionally used fasteners that are often difficult to clean and sterilize, thereby improving the quality of patient care and facilitating cleaning of patient and/or operating rooms.

RELATED APPLICATIONS

The present application claims priority to and benefit of U.S.Provisional Application No. 62/709,380, filed on Jan. 16, 2018, theentire teachings of which is incorporated by reference herein.

FIELD

The present disclosure generally relates to limb holders, such as limbholders used before, during, and after surgical procedures forsupporting patient's limbs, and related methods for making same.

BACKGROUND

During most surgical operations, nurses and surgical and support staffare often responsible for tending to the general health and safety of apatient. For example, nurses and surgical staff often tend to patientswhile they are under anesthesia and/or while they are recovering after asurgical procedure. In doing so, nurses and surgical staff oftenconsider a variety of factors to ensure a patient's safety. For example,in addition to considering factors for mitigating possible risksassociated with the surgical procedure at hand, nurses and hospitalstaff must also ensure that the patient's possibly unconscious body isalso protected from possible physical injuries that may be caused byunwanted movement of the patient's body (e.g., unconscious movements andrepositioning of the patient while under anesthesia or sleeping).

To date, various approaches have been developed to standardize themeasures used to protect patients, including usage of padding on thesurfaces that come in contact with the patient. Since a patient'snatural defenses can be inhibited due to anesthesia, normal responses todiscomfort or pressure points, which would normally occur if the patientwere merely asleep, cannot be relied upon to prevent injury. As such,padding of the surfaces with which the patient's body may come incontact is often used to reduce and mitigate injury to the patient.

For example, the operating table surface in some operating rooms caninclude a thick pad cover that has been secured to the operating tablein order to protect the patient from surface pressure. Supportivedevices such as lithotomy stirrups (e.g., used to hold the legs up andapart during surgeries in which the patient is on his/her back or asupine position) can also be padded. to mitigate unwanted pressure. Suchlithotomy stirrup pads are often held in place using “hook and loop”fastening systems, such as VELCRO® brand fasteners.

Operating rooms can also contain surface and/or airborne contaminates(e.g., bacteria or viruses), which can put patients at the risk ofcontracting an infection. In fact, infections due to surface or airbornecontaminants, such as bacteria or viruses, are among other risks thatpatients in hospitals and operating rooms can face. For this reason,operating rooms are often cleaned between each procedure, including thepadding and other patient contact surfaces. Generally, any impediment toproper cleaning can put the patients' health and desired recovery atrisk.

Although operating rooms, paddings, and other patient surfaces areusually cleaned and disinfected between surgical procedures, anyimpediment to proper cleaning can put the patients' health and desiredrecovery at risk. For example, many fastening systems (e.g., traditionalhook and loop style fastening systems) used in common lithotomy stirrupsare often very difficult to clean. Specifically, traditional hook andloop fasteners can have many cervices, which can in turn render surfacecleaning impossible. The loop portion of these fasteners can also bevery difficult to surface clean due to its tendency for retainingfluids.

SUMMARY

The present disclosure relates to methods, apparatus, and correspondingsystems for securing a patient's limb, for example during a surgicalprocedure. Embodiments disclosed herein reduce the number of attachmentsused in traditional limb holders and eliminate parts that aretraditionally difficult to sterilize and/or clean.

In one aspects, apparatus and corresponding methods for attaching one ormore paddings to a limb support shell is disclosed. The apparatus andcorresponding method utilize discrete mating features between thepadding(s) and the shell to create a padded support system. Thedisclosed embodiments can remove the necessity for traditional “hook andloop” fastener systems, thereby improving the ability to clean thedevices and decreasing the tendency for the fastening system to entrapmicroscopic and macroscopic debris and/or organisms,

In another aspect, apparatus and corresponding methods that employdiscrete structures attached to a surface of one or more padding(s) andmating features, which are built into a limb support shell, aredisclosed. The mating features can be mounting openings that areconfigured to accept these discrete structures and remain engaged to thediscrete structures through a mechanical interference. The matingfeatures can he manually engaged, holding the padding and the shelltogether as a combined system until manually disengaged by the user.While in use as a padded support system, the mechanical interference canprovide sufficient resistance to prevent the pad from inadvertentlydisengaging from the shell during use.

In some aspects, a support structure for holding a patient's limb isdisclosed. The support structure can comprise a shell configured to atleast partially receive and support the patient's limb. The shell cancomprise at least one mounting opening. The support structure can alsocomprise a padding coupled to the shell and configured to provide aprotective surface for the patient's limb. The padding can comprise atleast one mounting structure configured to be coupled to the mountingopening and coupling of the at least one mounting structure to the atleast one mounting opening can he configured to provide an interferencefit that secures the padding to the shell.

In another aspect, a method for providing a support structure forholding a patient's limb is disclosed. The method can include couplingat least one mating opening disposed on a surface of a shell configuredfor at least partially receiving the patient's limb with at least onemating structure of a protective padding via an interference fit andreceiving the patient's limb on the protective padding.

In other examples, the aspects above, or any system, method, apparatusdescribed herein can include one or more of the following features.

The shell can comprise at least one of a thermoplastic material,polyethylene, polypropylene, Acrylonitrile Butadiene Styrene (ABS),structural foam, and formed sheet metal.

The at least one mounting structure can comprise a base configured to becoupled with/connect to an outer surface of the padding and a neckextending substantially orthogonally from the base. The neck cancomprise at least one interference ring.

Furthermore, the mounting structure can comprise at least one of aliquid injection molded silicone, thermoplastic elastomer, thermoplasticurethane, a rubber-like material, and a soft plastic.

Further, the at least one mounting opening can be configured to extendthrough a thickness of the shell. Additionally, or alternatively, themounting structure can he configured to extend through an entire lengthof the at least one mounting opening. Further, the at least a portion ofthe shell can comprise an inner wall and an outer wall and the mountingopening can be disposed on the outer wall of the shell.

In some embodiments, the mounting structure can be configured to expandon an inner surface of the outer wall of the shell to secure the paddingto the shell. Further, the at least one mounting structure can compriseat least one interference ring configured to provide the interferencefit that secures the padding to the shell. Additionally, oralternatively, the at least one portion of the interference ring can beconfigured to be larger in diameter than a diameter of the at least onemounting opening in which the at least one mounting structure isreceived.

Additionally, or alternatively, the at least one portion of the mountingstructure can comprise at least one of a generally square-shaped, agenerally rounded, and generally triangular-shaped cross section.Further, in some embodiments, the at least one mounting structurecomprises at least one extension configured to at least partially extendover an edge of the shell to couple the padding to an outer surface ofthe shell.

In sonic embodiments, the at least one extension can comprise a notchconfigured to engage a corresponding recess in the outer surface of theshell. Further, the notch and the corresponding recess can be compatiblyshaped so as to mate with one another.

Other aspects and advantages of the invention can become apparent fromthe following drawings and description, all of which illustrate thevarious aspects of the invention, by way of example only.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically illustrates a limb holder according to some aspectsdisclosed herein.

FIG. 2 schematically illustrates a limb holder according to someembodiments disclosed herein.

FIG. 3 schematically illustrates an exploded view of a support element.

FIG. 4A schematically illustrates a front view of a support elementpadding according to some embodiments disclosed herein.

FIG. 4B schematically illustrates a rear view of a support elementpadding according to some embodiments disclosed herein.

FIG. 5 schematically illustrates a shell according to some embodimentsdisclosed herein.

FIG. 6 schematically illustrates a limb holder according to someembodiments disclosed herein.

FIG. 7A schematically illustrates a cross-section of a mountingstructure secured in a mounting opening via an interface fit accordingto embodiments disclosed herein.

FIG. 7B -7G schematically illustrate several examples of mountingstructures according to some embodiments disclosed herein.

FIGS. 8A-8H schematically illustrate several examples of mountingstructures according to some embodiments disclosed herein.

FIGS. 9A-9E schematically illustrate examples of mounting structuresaccording to some embodiments disclosed herein.

FIGS. 10A-10B schematically illustrate examples of a shell and acorresponding padding according to some embodiments disclosed herein.

DETAILED DESCRIPTION

Patient limb support devices are often configured to hold and/or supportrelevant portion(s) of a patient's body using a substantially rigidframe that has been padded to protect the patient's body/limb from therigid frame. Such supporting devices are commonly used during surgicalprocedures (or during recovery or treatment), in which the patient'slimb needs to be elevated or safely held in place. The padding coveringthe rigid surface is often held in place through attachment to the rigidsupport frame.

FIG. 1 schematically illustrates a patient 101 in a lithotomy position.The term “lithotomy position,” as used herein is intended to refer to aposition (e.g., for surgical procedures or medical examinations), inwhich at least a portion of the patient's body 101 is maintained aboveor at the same level as the patient's hip. However, although describedin terms of the lithotomy position and shown as supporting the patient'slower body, the embodiments disclosed herein can be used in conjunctionwith any support device, apparatus, system, or mechanism used tosupport, maintain in place, and/or hold any part or portion of theanatomical structure of a patient. The term patient, as disclosedherein, can refer to a human or an animal patient. Further, althoughdescribed as being used during surgical procedures, the embodimentsdisclosed herein can be used to support a part of a patient's body atany point or time during examination, treatment, surgical procedures,and/or recovery.

Referring back to FIG. 1, a limb holder 100 according to some aspectsherein is illustrated. The limb holder 100 can be used to support anyportion of the patient's 101 anatomy (e.g., the patient's leg 110). Forexample, the limb holder 110 can be a lithotomy stirrup used to hold orelevate the patient's 101 leg 110. Although not shown in FIG. 1, itshould be noted that depending on the application at hand, one or morelimb holders 100 can be used (e.g., in a gynecological exam, a pair oflimb holders 100 can be used). The limb holder 100 can be used to holdthe patient's limb in space, relative to at least one surface 112 onwhich the remaining portions of the body of the patient 101 aredisposed. Although the term bed 112 is used hereinafter to refer to theat least one surface, the surface 112 can be the surface of a bed, anoperating table, an examination table, etc.

The limb holder 100 can comprise one or more support elements 116 thatare used to support at least one part of the limb. For example, as shownin FIG. 1, the limb holder 100 can comprise a support element 116(formed to resemble the rear portion of a boot in the example shown inFIG. 1) configured to support the lower portion 114 of the patient's leg110. In some implementation, the support element 116 can be configuredto support the at least one portion 114 of the limb by wrapping aroundand/or cradling the portion 114 of the limb. The support element 116 canbe padded to prevent injury to the patient.

The limb holder 100 can further comprise a support structure 118 that isconfigured to be coupled to the bed 112 via a mounting rail 120.Generally, any suitable means available in the art can be used toconnect and mount the support structure 118 to the mounting rail 120.For example, one or more clamps 121 can be used to connect the supportstructure 118 to the mounting rail 120. Generally, any suitable clamp orconnecting mechanism can be used. However, the type of clamp orconnecting mechanism used can depend on the required mating geometry(e.g., the type or shape of the corresponding mating/mounting featureson the mounting rail 120 and/or the support structure 118) and/or thedesired range of motion (the range of motion of the device 100).

FIG. 2 illustrates a limb holder 200 according to some embodimentsdisclosed herein. As noted previously, although shown as supporting aleg of the patient, the limb holder 200 can be used to support, any limband/or body part of the patient. Further, the limb holder 200 cancomprise any shape or size. For example, as shown in FIG. 2, the limbholder 200 can comprise a semi boot-shaped support element 116 that isconfigured to support a portion 114 of the patient's limb (e.g., leg).The support element 116 can be padded and configured to cradle thepatient's limb.

Specifically, the support element 116 can comprise a shell 212. Theshell 212 can be coupled to the support structure 118 via any suitablemeans available in the art. The shell 212 can also be configured tosupport one or more padding(s) 210. The padding 210 can comprise anysuitable padding or cushioning material. The padding 210 can beconfigured such that it is removable and/or replaceable. Specifically,as described with respect to FIG. 3, the padding 210 can be configuredsuch that it can be separated from the shell 212.

The support element 116 can further comprise a cover 214. The cover 214can be removably and replaceably or permanently coupled to the supportelement 116. Alternatively, or additionally, the cover 214 can beconfigured to be movable with respect to the support element 116.Generally, any suitable available mechanism can be used to couple thecover 214 to the support element 116 and/or provide the cover with therequired movement with respect to the support element 116.

The cover 214 can be configured such that it covers at least one portionof the patient's limb that is not covered and/or cradled by the supportelement 116. For example, as shown in FIG. 2, the support element cancomprise a half-boot structure that leaves the top portion T of thepatient's limb exposed/uncovered. The cover 214 can be configured, asshown in FIG. 2, to cover at least one part of the portion T that is notcovered by the support element 116. The cover 214 can function toprotect the patient's limb (body) from possible and/or inadvertent,unwanted impact that may occur during care, operation, treatment and/orrecovery.

As noted, the cover 214 can be an integral part of the support element116 and permanently coupled to the support element 116. Alternatively,the cover 214 can be a removable, replaceable, and independent componentthat is coupled via suitable mechanical means to the support element116. Further, although shown as being coupled to the side of the supportelement, the cover 214 can be coupled to any suitable part of thesupport element 116.

The shell 212 can comprise any suitable available material. For example,the shell 212 can comprise at least one of a thermoplastic material(e.g., polyethylene, polypropylene, or Acrylonitrile Butadiene Styrene(ABS)), structural foam, or formed sheet metal. Generally, the shell 212can be manufactured via any suitable manufacturing process such asinjection molding, rotational molding, thermoforming, or vacuum forming.

FIG. 3 schematically illustrates how a shell 212 of a support element116, such as the support element shown in FIG. 2, can secure a padding210. In the example shown in FIG. 3, the shell 212 is shown separatelyfrom the padding 210. Generally, any suitable means available in the artcan be used to connect and secure the padding 210 to the shell 212. Forexample, traditionally, one or more fasteners (e.g., Velcro® brandfasteners or hook and loop fasteners) are used to secure the padding 210to the shell 212.

In the example shown in FIG. 3, a hook 310 is attached to an insidesurface 312 of the shell 212. Generally, any suitable means can be usedto connect the hook 310 to the shell. For example, an adhesive, one ormore staples, one or more screws, or a combination thereof can be usedto secure the hook 310 to the surface 312. Similarly, a loop 314 can beattached to underside surface 313 of the padding 210 in an areacorresponding to the area of the shell 212, to which the hook 310 isattached. The loop 314 can be attached to the padding using any suitablemeans available in the art. For example, the loop 314 can be sewn and/oradhered to the padding 210. Further, the lateral and medial sides of thepadding 210 can be secured using loop flaps 316 to corresponding hookpatches 318 on an outer surface 320 of the shell 212.

FIG. 4A-4B illustrate a padding 400 according to some embodimentsdisclosed herein. Although described as having a single padding 400, oneor more paddings 400 can be used with embodiments disclosed herein. Asshown in FIG. 4A, which illustrates a front view of the padding 400, thepadding 400 can comprise one or more mounting structures 410 secured toan outer surface 412 of the padding 400.

The mounting structures 410 can be in the form of protruding pins thatcan be inserted into respective mounting openings 510 (shown later inFIG. 5) to secure the padding 400 to a shell 500 (later shown in FIG.5). For example, in the embodiment shown in FIG. 4A, the mountingstructures 410 are disposed on the outside of the lateral wing 414 andnear the lateral ankle section 416 of the padding 400. Additionalmounting structures 410 can also he utilized. For example, as shown inFIG. 4B, the padding 400 can include any number of mounting structures410 (for example, three structures as shown in FIG. 4B) on an outsidesurface of the medial wing 418, on a medial ankle section 420, and on anouter surface of the upper toe section 422. Generally, any number ofmounting structures 410 can be used. The number of mounting structures410 can depend on the level of mounting security that the padding 400 isdesired to have, once mounted and secured by the shell 500 (shown inFIG. 5).

The mounting structures 410 can be secured to the surface of the padding400 using any suitable means available in the art, such as but notlimited to adhesives, sewing, and/or other physical and/or chemicalmeans. Alternatively or additionally, the mounting structures 410 can bemolded into the padding 400, passed through hole(s) disposed in thepadding (not shown), or upholstered in the padding 400.

The mounting structures 410 can be configured such that they are onlyexposed on the outer surface 412 of the padding 400. The exposedsurfaces 411 of the mounting structures 410 are, therefore, the onlysurfaces that need to be cleaned, disinfected, and/or kept sterile.Further, since the external surfaces 411 of the mounting structures 410are configured such that they protrude/project out of the padding, thesesurfaces can be easily cleaned using common methods for disinfectingsurfaces in hospitals and/or operating rooms. Accordingly, by utilizingmounting structures 410 as disclosed herein, embodiments of the presentdisclosure reduce and minimize potential entrapment of debris ororganisms in the padding, thereby providing superior means for securingthe padding 400 to the shell 500 over commonly used hook and loopfastening systems with regard to infection control,

The mounting structures 410 can be configured for mating withcorresponding mounting openings of a shell. FIG. 5 schematicallyillustrates a shell 500 according to some embodiments disclosed herein.As shown in FIG. 5, the shell 500 can comprise a plurality of mountingopenings 510 each configured to receive a corresponding mountingstructure 410 of the padding 400. As explained with reference to themounting structures 410, generally any number of mounting openings 510can be used and the mounting openings 510 can be disposed at anysuitable location on the shell 500. Further, the number of mountingopenings 510 and the mounting structures 410 need not be the same. Forexample, in some embodiments, the shell 500 can have more mountingopenings 510 than the mounting structures 410 provided in the padding400. Generally, the number of mounting openings 510 utilized can dependon the level of mounting security that the padding 400 is desired tohave, once mounted and secured by the shell 500. By way of example, thenumber of mounting structures 410 and the mounting openings 510 can bein a range of about two to about ten, although other numbers of mountingstructures 410 and mounting openings 510 can be used,

The mounting openings 510 can comprise any suitable shape and size. Theopenings 510 can further be configured such that they can accommodatethe size and shape of the mounting structures 410. Generally, thelocation of the mounting openings 510 on the shell 500 can be configuredto ensure that they correspond to and/or match the locations of themounting structures 410 on the padding 400.

Further, the mounting openings 510 can be configured to be throughholes. Specifically, the mounting openings 510 can be configured suchthat they pass through from the inner surface 512 to the outer surface514 of the boot shell 500. The mounting openings 510 can further beconfigured to provide a mechanical interference fit with the mountingstructures 410 on the padding 400.

FIG. 6 schematically illustrates a limb support 600 according to someembodiments disclosed herein. As shown, the limb support 600 comprises apadding 400 that is secured to an inner surface of a shell 500 via aninterface fit between the mounting structures 410 of the padding 400 andmounting openings 510 of the shell 500. The interface fit is formed viaengagement between a given mounting structure 410 and a correspondingmounting opening 510.

FIG. 7A schematically illustrates a cross-sectional view of interfacefit established via engagement of a mounting structure 410 and amounting opening 510. As shown, a mounting structure 410 can comprise abase 710 disposed and attached to an outer surface 412 of the padding400.. The mounting structure 410 can further comprise a neck section 712configured to protrude substantially perpendicularly out of the base 710of the mounting structure 410.

As noted, the mounting openings 510 of the shell 500 can comprise anysuitable shape. For example, the mounting openings 510 can be circular,elliptical, triangular, and/or trapezoidal. Further, the mountingopenings 510 can be implemented in the shell using any suitabletechnique available in the art. For example, the mounting openings 510can be bored, cut, or molded into the shell 500. The circumference 720of at least one mount opening 510 can be configured to allow theinterference ring 714 to compress inward while passing through themounting opening 510. The interference ring 714 can be configured suchthat, once passed through the mounting opening 510 and the circumference720 of the mount opening 510, the interference ring 714 expandsoutwardly to secure the padding 400 against the outer surface 514 of theshell 500.

The engagement of the interference ring 714 and the mounting opening 510forms a mechanical interference fit configured to resist an incidentalaxial force 716 caused, for example, as a result of inserting apatient's limb into the shell 500. The incidental axial force 716 can,alternatively or additionally, be caused from inadvertent pressureresulting from users leaning or pushing against the mounting structure410 or force exerted by other equipment used in conjunction with thelimb holder and/or pushing against the mounting structure 410.

The mechanical interference fit between the neck section 712 and theinner surface of the mounting opening 510 thereby provides a resistivecounter force 717 configured to restrict relative lateral movement 718of the outer surface 412 of the padding 400 and the inner surface 512 ofthe shell 400, such as lateral force caused by movement of the patient'slimb(s) against the padding 400, or adjustment of the padding 400.

As noted above, mounting structures and mounting openings disclosedherein can comprise any suitable shape and size and be disposed at anysuitable location on the shell and/or the padding. For example, as shownin FIG. 7C, the mounting opening can be a slot 1012 having a seat 1010configured to receive the neck portion 712 of a mounting structure 410.The padding 400 can be secured against the shell 500 by pressing/pushingthe neck 712 of the mounting structure 410 in a downward motion 1016through the slot 1012, overcoming an interference fit between the outerdimensions of the neck 712 and the inner dimension of the slot 1012until the neck 712 is seated in the seat 1010. As shown in FIG. 7D, oncethe mounting structure 410 is positioned within the seat 1010, thedimensional interference retains the neck 712 from moving opposite thedirection of the arrow 1016, while the dimensional interference betweeninterference ring 714 and the seat 1010 resists the incidental axialforce 716 thereby securing the mounting structure 410 in the slot 1012.

Further, as shown in FIGS. 7D-7G, the mounting opening can comprise anysuitable shape, including but not limited to a key-hole shaped slot 1018(shown in FIG. 7E) and/or a shaped slot 1014 (shown in FIG. 7G).

Generally, mounting structures 410 can comprise any suitable shaperequired to accommodate the shape of their corresponding mountingopenings. For example, as shown in FIG. 7F, in implementations thatutilize a key-hole shaped slot 1018 (FIG. 7E), a mounting structure 1020having an accommodating shape a key-shaped configuration) can be used,which can allow the mounting structure to mate with the respectiveopening so as to couple the padding to the shell.

Similarly, as shown in FIG. 7G, a U-shaped slot 1014 with acorresponding mounting structure 410 having an accommodating shape canhe utilized. The U-shaped slot 1014 can be disposed at any suitableposition on the shell 500. For example, as shown in FIG. 7G, theU-shaped slot 1014 can be positioned at an upper edge of the shell 500such that mounting structure 410 with the neck 712 and interference ring714, attached to padding 400, can be moved downward, along a direction1016, to secure padding to boot shell 500 (not shown).

FIGS. 8A- 8H schematically illustrate non-limiting examples of mountingstructures 410 that can be used with the embodiments disclosed herein.As shown and noted previously, the mounting structure can comprise anysuitable shape and size known and available in the art. The neck section712 of the mounting structure 410 can also comprise any suitable shapeand size known and available in the art. For example, the mountingstructure 410 can comprise a neck cross-section having a square 810(FIG. 8A), triangular 812 (FIG. 8B), and non-rectilinear 814 (FIG. 8C),or circular 816 (FIG. 8D) shape.

Further, the interface ring 714 can comprise any suitable shape and/orsize known and available in the art and be disposed at any suitableposition on the mounting structure 410. For example, as shown in FIGS.8E-8F, the interface ring 714 can be positioned at or near the tip 711of the mounting structure 410. Alternatively or additionally, as shownin FIG. 8G, the interference ring 714 can be positioned at any locationbelow the tip 711 of the mounting structure 410. Further, as shown inFIG. 8H, the mounting structure 410 can comprise one or moreinterference rings 714, 714′, 714″. Furthermore, the interference ring714 can comprise any suitable size and shape available in the art. Forexample, as shown in FIGS. 8E-8F, the interference ring 714 can comprisea rounded tip (FIG. 8E) or a flat tip (FIG. 8F),

Additionally, or alternatively, a bent-shaped mounting structure can beused to couple the padding 400 to the shell 500. For example, as shownin FIG. 9A, a mounting structure 910 can comprise a rounded (or bent)portion 901 that is configured to clip and extend over an edge 916 ofthe shell 500. The rounded portion of the mounting structure that clipsand extends over the edge 916 of the shell 500 can comprise a protrusionor a nub 912 that is configured to mate with a corresponding indentation(notch) 914 disposed on the outer surface 514 of the shell 500.Regardless of whether the mounting structure comprises the nub 912and/or whether the shell comprises the notch 914, the mounting structure910 can be configured such that upon being passed over the edge 916 ofthe shell, the mounting structure 910 remains flush with the edge 916.

In some implementations, the shell 500 can include one or more throughholes 924 configured to receive a bent-shaped mounting structure 910.Specifically, as shown in FIG. 9B, the shell 500 can include one or morethrough holes 924 configured to receive a portion of the mountingstructure 910. The mounting structure 910 can be configured such that itcan pass through the through hole 924 and clip over a portion of theouter surface 514 of the shell 500. The rounded portion of the mountingstructure that clips and extends through the through hole 912 cancomprise a nub 912 that is configured to mate with a correspondingindentation (notch) 914 disposed on the outer surface 514 of the shell500.

In embodiments that utilize the nub and notch configuration, themounting structure 910 can be coupled to the shell by engaging the nub912 in the notch 914. Similarly, the mounting structure 910 can bedisengaged from the shell by pulling an outer leg 920 of the bentmounting structure 910 to disengage the nub 912 from the compatiblyshaped mating notch 914 and lift the bent mating structure off of theshell edge 916. Generally, the nub and notch can comprise any suitableshape and size and be disposed at any suitable location on the matingstructure (nub) or the shell (notch).

Further, as shown in FIG. 9D, the through hole 922 can comprise a notch918 on at least one of its internal surfaces 917. Although shown asbeing disposed on one side 922A of the shell, the notch 918 can bedisposed on the surface 917 of one or both 922A, 9229 portions of theshell 500. The notch 918 can be configured such that it can receive amounting structure 910 (shown in FIG. 9D). In this embodiment, themounting structure 910 comprises an extension 977 that clips over thenotch 918, disposed on the internal surface 917 of the shell portion922A, and extends over the external/outer surface 514. Further, as shownin FIG. 9E, the extension 977 can comprise a mating feature 999 that isconfigured to mate with the indentation 914 disposed on the externalsurface 514 of the shell 500. The coupling of the mating feature 999with the indentation 914 can further secure the padding to the shell.Specifically, a user can secure the padding 400 against the shell 500 bypassing the extension 977 over the notch 918 (which can be a U-shapednotch) such that the extension extends over the surface/wall 514 of theshell. This configuration places the upper part 998 of the mountingstructure 910 in the notch 918, thereby securing the mounting structure910 against the surface' 514 of the shell 500. The engagement of themating feature 999 with the notch 914 can be utilized to further securethe padding to the shell. In some embodiments, the extension 977 can beconfigured such that upon passing of the extension 977 over the notch918, the extension 977 is flush with the top edge of the shell.

The mounting structure 910 can be attached to the padding 400 using anysuitable means available in the art. For example, the mounting structure910 can be glued to the padding 400 and/or molded in the padding 400.Further, the mounting structure 998 can comprise any suitableconfiguration or materials and be formed using any suitable technique,including but not limited to injection molding (for thermos-plastics) orreaction injection molding (such as structural foam). In someimplementations, the mounting structure 998 can be cut from any suitablematerial available in the art.

FIG. 10A schematically illustrates a shell 1110 according to someembodiments disclosed herein. Generally, the shell can comprise anyconfiguration or material and formed using any suitable manufacturingtechniques, such as injection molding, roto-molding (forthermoplastics), or reaction injection molding (for structural foams).For example, the shell can be a double-walled or thick-walled structure1110 having a thickness 1112 formed by an inner wall 1120, an outer wall1116, and a space 1118 between the inner wall 1120 and the outer wall1116. Alternatively, the shell can be a solid single layer ormulti-layer structure.

The space 1118 can be a void space or a filled space. For example, thespace 1118 can be filled with a foamed material. The space 1118 can hefilled with material foamed based on the process used to form the shell,during or after manufacture of the shell. Some examples of such foamedmaterial can include, without limitation, polyurethane, polyethylene, orPolyisocyanurate foams.

In some embodiments, the thickness of the shell can comprise a mountingfeature 1114, which can be provided within the thickness of the shelland configured to receive and engage a mounting structure 410 of thepadding. As shown in FIG. 1013, the mounting structure 410 can comprisean interference ring 1714 that is configured to expand, once passedthrough the opening of the mounting feature 1114, to secure the mountingstructure 410 to the mounting feature 1114.

Although this specification discloses advantages in the context ofcertain illustrative, non-limiting embodiments, various changes,substitutions, permutations, and alterations may be made withoutdeparting from the scope of the specification as defined by the appendedclaims. Further, any feature described in connection with any oneembodiment may also be applicable to any other embodiment.

What is claimed is:
 1. A support structure for holding a patient's limb,the support structure comprising: a shell configured to at leastpartially receive and support the patient's limb, the shell comprisingat least one mounting opening; and a padding coupled to the shell andconfigured to provide a protective surface for the patient's limb, thepadding comprising at least one mounting structure configured to becoupled to the mounting opening; wherein coupling of the at least onemounting structure to the at least one mounting opening is configured toprovide an interference fit that secures the padding to the shell. 2.The support structure of claim 1, wherein the shell comprises at leastone of a thermoplastic material, polyethylene, polypropylene,Acrylonitrile Butadiene Styrene (ABS), structural foam, and formed sheetmetal.
 3. The support structure of claim 1, wherein the at least onemounting structure comprises a base configured to be coupled with anouter surface of the padding and a neck extending substantiallyorthogonally from the base.
 4. The support structure of claim 3, whereinthe neck comprises at least one interference ring.
 7. The supportstructure of claim 1, wherein the at least one mounting opening isconfigured to extend through a thickness of the shell.
 8. The supportstructure of claim 7, wherein the mounting structure is configured toextend through an entire length of the at least one mounting opening,.9. The support structure of claim 8, wherein at least a portion of theshell comprises an inner wall and an outer wall and the mounting openingis disposed on the outer wall of the shell.
 10. The support structure ofclaim 9, wherein the mounting structure is configured to expand on aninner surface of the outer wall of the shell to secure the padding tothe shell.
 11. The support structure of claim 1, wherein the at leastone mounting structure comprises at least one interference ringconfigured to provide the interference fit that secures the padding tothe shell.
 12. The support structure of claim 11, wherein at least oneportion of the interference ring is configured to be larger in diameterthan a diameter of the at least one mounting opening in which the atleast one mounting structure is received.
 14. The support structure ofclaim 1, wherein the mounting structure comprises at least one of aliquid injection molded silicone, thermoplastic elastomer, thermoplasticurethane, a rubber-like material, and a soft plastic.
 15. The supportstructure of claim 1, wherein at least one portion of the Mountingstructure comprises at least one of a generally square-shaped, agenerally rounded, and generally triangular-shaped cross section. 16.The support structure of claim 1, wherein the at least one mountingstructure comprises at least one extension configured to at leastpartially extend over an edge of the shell to couple the padding to anouter surface of the shell.
 17. The support structure of claim 16,wherein the at least one extension comprises a notch configured toengage a corresponding recess in the outer surface of the shell.
 18. Thesupport structure of claim 17, wherein the notch and the correspondingrecess are compatibly shaped.
 19. The support structure of claim 1,wherein the at least one mounting structure is disposed within at apredetermined distance from an edge of the padding.
 20. The supportstructure of claim 1, wherein the mounting structure and the mountingopening are disposed at a predetermined distance from an upper edge ofthe shell.
 21. A method for providing a support structure for holding apatient's limb, the method comprising: coupling at least one matingopening disposed on a surface of a shell configured for at leastpartially receiving the patient's limb with at least one matingstructure of a protective padding via an interference fit; and receivingthe patient's limb on the protective padding.